Parexel Blog
Parexel Blog
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Learn MoreFormer FDA expert provides valuable advice on INTERACT programs for CBER products
Many sponsors of CBER-regulated products are familiar with pre-IND meetings, but there’s a new program called INTERACT, which stands for Initial Targeted Engagement for Regulatory Advice on CBER...
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English Requirement for FDA GMP Documents
Generally, overseas manufacturers in non-English speaking countries have their GMP documentation in the local language so that the staff working at the facility are able to read and understand the...
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#ParexelWithPride - Employee contributes to the landmark ruling in Botswana
On Tuesday, June 11, the High Court of Botswana issued a unanimous decision decriminalizing same-sex sexual conduct between consenting adults. The Southern Africa Litigation Centre (SALC) hailed...
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RIM Blog Series - Part 2: Mind the gap
As discussed in my previous paper, RIM started about 15 years ago and is a discipline that supports Life Sciences Regulatory Processes. In 2003, capturing Regulatory information was a...
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Learn MoreImproving the Odds of Success in Prostate Cancer Therapy Development
In recognition of Men’s Health Month, Parexel offers a deep dive into the challenges of developing therapies for prostate cancer. Despite significant research advances, prostate cancer remains...
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Thank you for Joining with Parexel to Mark International Clinical Trials Day
Over the last few weeks Parexel has been celebrating International Clinical Trials Day, aimed at raising awareness of the impact of clinical trials and honoring the patients participating in...
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Bispecific Antibody Development Program Guidance
Earlier this month FDA released a draft guidance called “Bispecific Antibody Development Programs”. This is a welcome addition to FDA’s set of guidance documents for biotechnology...
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Learn how to adapt innovative precision medicine trials from industry experts convened by Parexel
During an expert panel convened by Parexel and Pharma Intelligence in Santa Clara, industry leaders discussed the use and optimization of precision medicine trial strategies. ...
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Tina Aswani Omprakash shares her experience of living with Crohn’s disease and participating in a clinical trial
In her early 20s, Tina Aswani Omrakash was a busy, young professional living in New York City. Her life was then derailed and “the rug pulled out from under her” when she began a 10-year journey...
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RIM Blog Series - Part 1: It’s not a technology, it’s a discipline
Fifteen years after coining the term Regulatory Information Management (RIM), I still see many conversations and discussions taking place about “What is RIM”. To me, the definition has always...
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Parexel Celebrates International Clinical Trials Day
Every year, International Clinical Trials Day represents an opportunity to raise awareness of the impact of clinical trials and honor the people who help drive clinical research all over the...
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T.J. Sharpe shares his experience battling melanoma and participating in clinical trials
At the age of 25, T.J. Sharpe was diagnosed with melanoma, which was removed successfully. Years later, married and with two young kids, he learned his melanoma had returned with tumors in...
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The State of Germline Gene Editing. What We Don’t Know!
According to NIH “germline alteration involves a specific attempt to introduce genetic changes into the germ (reproductive) cells of an individual, with the aim of changing the set of genes passed...
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Learn MoreAsk the Expert Blog Series: Cystic Fibrosis
Bertrand Sohier, MD, is the Global Therapeutic Area Head for Pulmonology, Critical Care, Cardiovascular and Endocrinology within Parexel’s Global Medical Services division. A board-certified...
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Key Questions to Consider When Licensing Cell & Gene Therapy Products
Manufacturers often ask if there is a checklist for CMC readiness before entering pivotal or Phase III study or if they plan to ask the agency for one of many expediated designations. Since the...
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A New Day for Parexel
Over the last 37 years, Parexel has established a rich heritage focused on the development and commercialization of innovative new therapies for patients. Our colleagues around the world are...
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Unlocking Drug Development Innovation with the Right People, Processes & Culture
In this video, Albert Siu, Corporate Vice President, Learning & Development, discusses Parexel's multi-layered approach to ensuring the strength and integrity of our global workforce. To...
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The Parexel Podcast Episode 2: Tackling Rare Diseases & Inside the FDA
Recorded during the 2019 World Orphan Drug Congress, this episode brings together Amy McKee and Mo Heidaran who both recently joined PAREXEL from the FDA, as well as Zizi Imatorbhebhe,...
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Learn MoreCould Netflix-Style Pricing Spark A Renaissance in Antimicrobial Research
The discovery of penicillin heralded the first in a series of victories in the war against disease, providing the foundation for advances in surgery and medicine which would have been...
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Learn MoreAsk The Expert Blog Series: Malaria
Nathalie Sohier, MD, MPH is a Senior Medical Director and Global Therapeutic Area Head for Infectious Diseases and Vaccines within PAREXEL’s Global Medical Services division. Nathalie...
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